Fears over infectious outbreaks, from SARS to bird flu to the latest swine-borne virus, have boosted investment in vaccines and fostered fresh approaches
No one knows yet whether the flu outbreak in Mexico and in states like New York and California will turn into a major pandemic or a forgettable blip in the annals of infectious diseases. It's not even clear exactly what to call the virus, since it seems to have acquired genes from both pigs and birds on its evolutionary journey to making people sick. "As far as we know, this never happened before," says Laurie A. Garrett, senior fellow at the Council on Foreign Relations and author of The Coming Plague: Newly Emerging Diseases in a World Out of Balance. Maybe we should call it the swinebird flu.
The good news is that the world—especially the vaccine industry—is far better prepared to deal with a threat such as the new influenza virus than it was just a few years ago. Key decisions to rush through a vaccine have yet to be made. But governments around the world could move quickly to tap the industry's capability if the outbreak continues to worsen. One scenario floated by the Centers for Disease Control in Atlanta: The U.S. government could direct a drug company to drop some of its current development projects, create a swine flu vaccine, and start ramping up manufacturing.
An action like that would be costly and politically fraught. But the surprising thing is that such a step is even possible. That certainly was not the case during the flu season of 2004-2005. Back then, the pharmaceutical industry couldn't make enough vaccine for regular flu. There were only two companies in the business—Aventis Pasteur (now a unit of Sanofi-Aventis (SNY) and Chiron (since acquired by Novartis ( NVS ). One of Chiron's facilities had to be shut down during that outbreak because of safety concerns.
Egg-Cultivated Vaccines Take Time
What has occurred in the interim is a vaccine revival fueled by both improved profitability and an increase in government dollars. Three pharmaceutical giants now manufacture flu vaccine: Sanofi-Aventis, Novartis, and GlaxoSmithKline (GSK), along with small players such as MedImmune, a unit of AstraZeneca ( AZN ). These companies are already gearing up to make the vaccine for next winter's flu season. There's enough capacity among the players to ramp up production of swine flu vaccine—assuming funding is available—and still prepare for the regular flu season.
The bad news? The latest threat can't be squelched quickly or completely with a vaccine produced by traditional methods. The manufacturing process takes months because the virus first must be carefully grown in eggs, then harvested to be turned into a vaccine.
Yet there's possibly a way around this problem. Over the past few years, several companies have sprung up to develop methods for making vaccines more quickly, such as growing viruses in cells rather than eggs. These processes hold considerable promise, but none has been licensed yet by the Food & Drug Administration. One of the difficult decisions the Obama Administration will face if the epidemic threatens to spin out of control is whether to fast-track approval of one of these next-generation vaccines in order to make it available more quickly. "If this turns out to be a crisis, the government might go to one of the newer technologies that has quicker production," explains John Clerici, chair of the life sciences and public health practice at law firm McKenna Long & Aldridge. The bigger the crisis, the greater the tolerance for regulatory risks.
Courtesy article by John Carey appearing in Business Week on April 28, 2009
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